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Last Updated: October 4, 2024

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trikafta (copackaged) Drug Patent Profile


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When do Trikafta (copackaged) patents expire, and what generic alternatives are available?

Trikafta (copackaged) is a drug marketed by Vertex Pharms Inc and is included in two NDAs. There are thirty-two patents protecting this drug.

This drug has four hundred and ninety-nine patent family members in forty-four countries.

The generic ingredient in TRIKAFTA (COPACKAGED) is elexacaftor, ivacaftor, tezacaftor; ivacaftor. One supplier is listed for this compound. Additional details are available on the elexacaftor, ivacaftor, tezacaftor; ivacaftor profile page.

DrugPatentWatch® Generic Entry Outlook for Trikafta (copackaged)

Trikafta (copackaged) was eligible for patent challenges on October 21, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 8, 2037. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for trikafta (copackaged)
Drug patent expirations by year for trikafta (copackaged)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for trikafta (copackaged)
Generic Entry Dates for trikafta (copackaged)*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, TABLET;ORAL
Generic Entry Dates for trikafta (copackaged)*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULES;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for trikafta (copackaged)

trikafta (copackaged) is protected by seventy-seven US patents and seven FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of trikafta (copackaged) is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting trikafta (copackaged)

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621

Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621

Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA

Pharmaceutical composition and administrations thereof
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Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO

Pharmaceutical composition and administrations thereof
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Modulators of cystic fibrosis transmembrane conductance regulator
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of cystic fibrosis transmembrane conductance regulator
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of cystic fibrosis transmembrane conductance regulator
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of cystic fibrosis transmembrane conductance regulator
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Pharmaceutical composition and administrations thereof
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Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO

Pharmaceutical compositions for treating cystic fibrosis
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Pharmaceutical compositions for treating cystic fibrosis
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO AT LEAST ONE OF CLAIMS 1-9 OF US11179367

Modulators of cystic fibrosis transmembrane conductance regulator
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of cystic fibrosis transmembrane conductance regulator
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407


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Methods of treatment for cystic fibrosis
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Methods of treatment for cystic fibrosis
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (200 MG OR 100 MG); TEZ; AND IVA


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Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO


Patent Number: ⤷  Sign Up
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Patented Use: TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1


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Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO


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Patented Use: TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER


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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO


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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA


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Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
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Indole derivatives as CFTR modulators
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Modulators of ATP-binding cassette transporters
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Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE ONE F508DEL MUTATION AND ONE R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
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Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
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Pharmaceutical composition and administrations thereof
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Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarbox- amide and administration thereof
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR

Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarbox- amide and administration thereof
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
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Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
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Patented Use: TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
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Patented Use: TREATMENT OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
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Patented Use: TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA

Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
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Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO

Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
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Patented Use: TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA

Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
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Patented Use: TREATMENT OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR

Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
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Patented Use: TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Sign Up
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Sign Up
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Sign Up
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

FDA Regulatory Exclusivity protecting trikafta (copackaged)

TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA
Exclusivity Expiration: ⤷  Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

NEW PRODUCT
Exclusivity Expiration: ⤷  Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 6 THROUGH 11 YEARS OLD WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA
Exclusivity Expiration: ⤷  Sign Up

INDICATED FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-002 Jun 8, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor GRANULES;ORAL 217660-002 Apr 26, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for trikafta (copackaged)

When does loss-of-exclusivity occur for trikafta (copackaged)?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 0346
Patent: MODULADOR DEL REGULADOR DE CONDUCTANCIA TRANSMEMBRANA DE FIBROSIS QUÍSTICA, COMPOSICIONES FARMACÉUTICAS, MÉTODOS DE TRATAMIENTO Y PROCESO PARA PRODUCIR EL MODULADOR
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 17371200
Patent: Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Estimated Expiration: ⤷  Sign Up

Patent: 21211993
Patent: MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR
Estimated Expiration: ⤷  Sign Up

Patent: 23203944
Patent: MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2019011626
Patent: modulador de regulador de condutância transmembrana na fibrose cística, composições farmacêuticas, métodos de tratamento e processo para a produção do modulador
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 46086
Patent: MODULATEUR DE REGULATEUR DE CONDUCTANCE TRANSMEMBRANAIRE DE FIBROSE KYSTIQUE, COMPOSITIONS PHARMACEUTIQUES, PROCEDES DE TRAITEMENT ET PROCEDE DE FABRICATION DU MODULATEUR (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 19001553
Patent: Modulador del regulador de conductancia transmembrana de fibrosis quística, composiciones farmacéuticas, métodos de tratamiento y proceso para producir el modulador.
Estimated Expiration: ⤷  Sign Up

China

Patent: 0267948
Patent: 囊性纤维化跨膜传导调控剂的调节剂、药物组合物、治疗方法和制备所述调节剂的方法 (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR)
Estimated Expiration: ⤷  Sign Up

Patent: 7843619
Patent: 囊性纤维化跨膜传导调控剂的调节剂、药物组合物、治疗方法和制备所述调节剂的方法
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 19007129
Patent: Modulador del regulador de conductancia transmembrana de fibrosis quística, composiciones farmacéuticas, métodos de tratamiento y proceso para producir el modulador
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0201946
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 23736
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 51622
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 19048759
Patent: MODULADOR DEL REGULADOR DE CONDUCTANCIA DE TRANSMEMBRANA DE FIBROSIS QUÍSTICA, COMPOSICIONES FARMACÉUTICAS, Y PROCESO PARA PRODUCIR EL MODULADOR
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 9280
Patent: МОДУЛЯТОР РЕГУЛЯТОРА ТРАНСМЕМБРАННОЙ ПРОВОДИМОСТИ ПРИ МУКОВИСЦИДОЗЕ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СПОСОБЫ ЛЕЧЕНИЯ И СПОСОБ ПОЛУЧЕНИЯ УКАЗАННОГО МОДУЛЯТОРА (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR)
Estimated Expiration: ⤷  Sign Up

Patent: 1991403
Patent: МОДУЛЯТОР РЕГУЛЯТОРА ТРАНСМЕМБРАННОЙ ПРОВОДИМОСТИ ПРИ МУКОВИСЦИДОЗЕ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СПОСОБЫ ЛЕЧЕНИЯ И СПОСОБ ПОЛУЧЕНИЯ УКАЗАННОГО МОДУЛЯТОРА
Estimated Expiration: ⤷  Sign Up

Patent: 2192783
Patent: МОДУЛЯТОР РЕГУЛЯТОРА ТРАНСМЕМБРАННОЙ ПРОВОДИМОСТИ ПРИ МУКОВИСЦИДОЗЕ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СПОСОБЫ ЛЕЧЕНИЯ И СПОСОБ ПОЛУЧЕНИЯ УКАЗАННОГО МОДУЛЯТОРА
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 51622
Patent: MODULATEUR DE RÉGULATEUR DE CONDUCTANCE TRANSMEMBRANAIRE DE FIBROSE KYSTIQUE, COMPOSITIONS PHARMACEUTIQUES, PROCÉDÉS DE TRAITEMENT ET PROCÉDÉ DE FABRICATION DU MODULATEUR (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR)
Estimated Expiration: ⤷  Sign Up

Patent: 12379
Patent: FORME CRYSTALLINE D'UN N-(PYRAZOL-4-YL)SULFONYL-6-(PYRAZOL-1-YL)-2-(PYRROLIDIN-1-YL)PYRIDINE-3-CARBOXAMIDE POUR TRAITER LA MUCOVISCIDOSE (CRYSTALLINE FORM OF A N-(PYRAZOL-4-YL)SULFONYL-6-(PYRAZOL-1-YL)-2-(PYRROLIDIN-1-YL)PYRIDINE-3-CARBOXAMIDE FOR TREATING CYSTIC FIBROSIS)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 52205
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 7048
Patent: אפנן וסת של מוליכות טראנסממברנלית בציסטיק פיברוזיס, תכשירים פרמצבטים, שיטות טיפול, ותהליך ליצירת האפנן (Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator)
Estimated Expiration: ⤷  Sign Up

Patent: 7491
Patent: אפנן וסת של מוליכות טראנסממברנלית בציסטיק פיברוזיס, תכשירים פרמצבטים, שיטות טיפול, ותהליך ליצירת האפנן (Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator)
Estimated Expiration: ⤷  Sign Up

Patent: 4237
Patent: אפנן וסת של מוליכות טראנסממברנלית בציסטיק פיברוזיס, תכשירים פרמצבטים, שיטות טיפול, ותהליך ליצירת האפנן (Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 16285
Estimated Expiration: ⤷  Sign Up

Patent: 73522
Estimated Expiration: ⤷  Sign Up

Patent: 20500906
Patent: 嚢胞性線維症膜コンダクタンス制御因子の調節物質、医薬組成物、治療方法、及び調節物質の作製プロセス
Estimated Expiration: ⤷  Sign Up

Patent: 21119172
Patent: 嚢胞性線維症膜コンダクタンス制御因子の調節物質、医薬組成物、治療方法、及び調節物質の作製プロセス (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING MODULATOR)
Estimated Expiration: ⤷  Sign Up

Patent: 23154048
Patent: 嚢胞性線維症膜コンダクタンス制御因子の調節物質、医薬組成物、治療方法、及び調節物質の作製プロセス (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING MODULATOR)
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 0190125
Patent: مُعدِّل‏ لمنظم موصلية التليف الكيسي عبر الغشاء، وتركيبات صيدلانية، وطرق للعلاج، وعملية لتصنيع المُعدِّل (Modulator of Cystic Fibrosis Transmembrane Conductance Regulator, Pharmaceutical Compositions, Methods of Treatment, and Process for Making the Modulator)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 51622
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 19006637
Patent: MODULADOR DEL REGULADOR DE CONDUCTANCIA TRANSMEMBRANA DE FIBROSIS QUISTICA COMPOSICIONES FARMACEUTICAS METODOS DE TRATAMIENTO Y PROCESO PARA PRODUCIR EL MODULADOR. (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR.)
Estimated Expiration: ⤷  Sign Up

Patent: 21013639
Patent: FORMA CRISTALINA DEL COMPUESTO 1, UN MODULADOR DEL REGULADOR DE CONDUCTANCIA TRANSMEMBRANA DE FIBROSIS QUÍSTICA, PROCESOS PARA SU PREPARACIÓN, COMPOSICIONES FARMACÉUTICAS DEL COMPUESTO 1, Y SU USO EN EL TRATAMIENTO DE FIBROSIS QUÍSTICA. (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR.)
Estimated Expiration: ⤷  Sign Up

Moldova, Republic of

Patent: 51622
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 235
Patent: MODULATEUR DE RÉGULATEUR DE CONDUCTANCE TRANSMEMBRANAIRE DE FIBROSE KYSTIQUE, COMPOSITIONS PHARMACEUTIQUES, PROCÉDÉS DE TRAITEMENT ET PROCÉDÉ DE FABRICATION DU MODULATEUR
Estimated Expiration: ⤷  Sign Up

Patent: 847
Patent: FORME CRYSTALLINE D'UN N-(PYRAZOL-4-YL)SULFONYL-6-(PYRAZOL-1-YL)-2-(PYRROLIDIN-1-YL)PYRIDINE-3-CARBOXAMIDE POUR TRAITER LA MUCOVISCIDOSE
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 4805
Patent: Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 191304
Patent: MODULADOR DEL REGULADOR DE CONDUCTANCIA DE TRANSMEMBRANA DE FIBROSIS QUISTICA, COMPOSICIONES FARMACEUTICAS, METODOS DE TRATAMIENTO Y PROCESO PARA PRODUCIR EL MODULADOR
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 51622
Estimated Expiration: ⤷  Sign Up

Saudi Arabia

Patent: 9401947
Patent: مُعدِّل منظم التوصيل عبر الأغشية للتليف الكيسي، تركيبات صيدلية، طرق علاج، وعملية لتحضير المُعدِّل (Modulator of Cystic Fibrosis Transmembrane Conductance Regulator, Pharmaceutical Compositions, Methods of Treatment, and Process for Making the Modulator)
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 150
Patent: MODULATOR REGULATORA TRANSMEMBRANSKE PROVODLJIVOSTI CISTIČNE FIBROZE, FARMACEUTSKE KOMPOZICIJE, POSTUPCI LEČENJA, I POSTUPAK ZA DOBIJANJE MODULATORA (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201913606V
Patent: MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 51622
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1904062
Patent: MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2269492
Estimated Expiration: ⤷  Sign Up

Patent: 190101993
Patent: 낭포성 섬유증 막관통 전도성 조절인자의 조절제, 약제학적 조성물, 치료 방법, 및 상기 조절제를 제조하는 방법
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 37431
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 74712
Estimated Expiration: ⤷  Sign Up

Patent: 1835065
Patent: Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 513
Patent: MODULADOR DEL REGULADOR DE CONDUCTANCIA TRANSMEMBRANA DE FIBROSIS QUÍSTICA, COMPOSICIONES FARMACÉUTICAS, MÉTODOS DE TRATAMIENTO Y PROCESO PARA PRODUCIR EL MODULADOR
Estimated Expiration: ⤷  Sign Up

Patent: 723
Patent: MODULADOR DEL REGULADOR DE CONDUCTANCIA TRANSMEMBRANA DE FIBROSIS QUÍSTICA, COMPOSICIONES FARMACÉUTICAS, MÉTODOS DE TRATAMIENTO Y PROCESO PARA PRODUCIR EL MODULADOR
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering trikafta (copackaged) around the world.

Country Patent Number Title Estimated Expiration
Japan 2012107069 MODULATOR OF ATP-BINDING CASSETTE TRANSPORTER ⤷  Sign Up
Argentina 114581 COMPOSICIONES FARMACÉUTICAS PARA TRATAR LA FIBROSIS QUÍSTICA ⤷  Sign Up
Jordan P20190125 مُعدِّل‏ لمنظم موصلية التليف الكيسي عبر الغشاء، وتركيبات صيدلانية، وطرق للعلاج، وعملية لتصنيع المُعدِّل (Modulator of Cystic Fibrosis Transmembrane Conductance Regulator, Pharmaceutical Compositions, Methods of Treatment, and Process for Making the Modulator) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for trikafta (copackaged)

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1773816 PA2015028 Lithuania ⤷  Sign Up PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
2826776 CA 2021 00013 Denmark ⤷  Sign Up PRODUCT NAME: A COMBINATION OF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) ....; REG. NO/DATE: EU/1/18/1306 20181106
1773816 CA 2015 00038 Denmark ⤷  Sign Up PRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.